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Clinical studies of Shengjinrunzaoyanyxue Granules on treating Sjogren syndrome
Author(s): QIAN Xian, HU Wei, GUO Feng, ZHANG Miu-jia, TAO Juan, GAO Zhong-en, ZHOU Zheng-qiu, Jiangsu Province Hospital of TCM, Nanjing Hospital of TCM, Jiangsu People’s Hospital, Wuxi Hospital of TCM, Suzhou Hospital of TCM, Changzhou Hospital of TCM
Pages: 3663-
3666
Year: 2014
Issue:
11
Journal: China Journal of Traditional Chinese Medicine and Pharmacy
Keyword: Shengjinrunzaoyangxue Granules; Sjogren syndrome; Yin-deficiency and depletion of fluid syndrome; randomized controlled trial;
Abstract: Objective: To observe the ei cacy and safety evaluation of Shengjinrunzaoyangxue Granules on relieving symptoms of dry eye and dry mouth in primary Sjogren syndrome patients with yin-dei ciency and depletion of l uid syndrome. Methods: Two hundreds and forty patients with yin-dei ciency and depletion of l uid syndrome were grouped by a computergenerated randomized grouping design. The dosage regimen was devised as Shengjinrunzaoyangxue Granules or placebo granules(in ratio of 2:1) were given 1 dose per day for 6 weeks. The primary end point was change of the Schirmer test, salivary low rate, speed of sugar test. The secondary end point was the score of dry eyes and dry mouths. Results: After 6 weeks: The results of intention-to-treat analysis and per-protocol analysis showed that the dif erence value of Schirmer test for the left eyes were 1.8mm/5min(95% coni dence interval: 0.37-3.22) and 1.82mm/5min(95% coni dence interval: 0.32-3.31), and the value of Schirmer test for the right eyes were 2.77mm/5min(95% coni dence interval∶1.26-4.28) and 2.81mm/5min(95% coni dence interval: 1.23-4.39). The dif erence has statistical signii cance in post-treatment intergroup comparison and intragroup comparison(P<0.05). The results of intention-to-treat analysis and per-protocol analysis showed the dif erence value of salivary low rate were 0.04mL/15min(95% coni dence interval: 0.49-0.85) and 0.04mL/15min(95% coni dence interval: 0.52-0.60). There was no statistical signii cance in post-treatment intergroup comparison(P<0.05). The results of intention-to-treat analysis and per-protocol analysis showed the dif erence value of speed of sugar test were 1.17min(95% coni dence interval: 0.11-3.44) and 1.84min(95% coni dence interval: 0.12-3.55). And there was no statistical signii cance in post-treatment intergroup comparison(P<0.05). There was a signii cant improvement of the scores of dry eyes and dry mouths. And the dif erence has statistical signii cance(P<0.05).There were no statistically dif erences(P<0.05) in the incidence of adverse events. Conclusion: Shengjinrunzaoyangxue Granulesmay improve symptoms of dry eye and dry mouth, lacrimal low rate with high security.
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